Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
- Conditions
- Heart Failure
- Interventions
- Device: AV Delay programming through cardiac resynchronization therapy
- Registration Number
- NCT00677014
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.
- Detailed Description
SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1060
- Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
- Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
- Patients who are on optimal and stable pharmacologic therapy
- Patients who are expected to be in sinus rhythm at the time of implant
- Patients who have a life expectancy of more than 360 days, per physician's discretion
- Patients who are geographically stable and willing to comply with the required follow-up schedule
- Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law
- Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients who have previously received cardiac resynchronization therapy
- Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
- Patients who are pregnant or planning to become pregnant during the study
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Echo optimized AV delay AV Delay programming through cardiac resynchronization therapy Echo optimized AV delay Algorithm optimized AV delay AV Delay programming through cardiac resynchronization therapy Algorithm optimized AV delay Fixed AV Delay AV Delay programming through cardiac resynchronization therapy Fixed AV Delay
- Primary Outcome Measures
Name Time Method Left Ventricular End-systolic Volume (LVESV) 6 months Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
- Secondary Outcome Measures
Name Time Method Secondary Endpoints Will Include Structural and Functional Measures Chronic
Trial Locations
- Locations (1)
Medical College of Virginia
🇺🇸Richmond, Virginia, United States
Medical College of Virginia🇺🇸Richmond, Virginia, United States